MAUDE Adverse Event Report: NEUROPACE, INC. NEUROPACE RNS SYSTEM

Model Number DL-344-3.5-K

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735)

Event Date 11/22/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).There is no indication of product failure or malfunction.The neurostimulator remains implanted and programmed per the physician.

Event Description

On 11/13/23 the patient presented with a large scab at frontal portion of incision site, a scab was loosened by a recent fall.There was an attempt at conservative management with dehiscence of incision approximately 1 week later.Treatment included antibiotics and surgery for wound washout/ reclosure.Oral antibiotics were provided for 10 days post surgery.The device remains implanted.Diagnosed as superficial incisional infection.Patient has recovered.

• Brand Name: NEUROPACE RNS SYSTEM
• Type of Device: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• Manufacturer (Section G): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• Manufacturer Contact: ramona gonis ; 455 n. bernardo ave.; mountain view, CA 94043 ; 5108822607
• MDR Report Key: 18331055
• MDR Text Key: 330526836
• Report Number: 3004426659-2023-00065
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005359
• UDI-Public: 010085554700535917260106
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: DL-344-3.5-K
• Device Catalogue Number: 1007930
• Device Lot Number: 33030-1-1-1
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 31 YR
• Patient Sex: Female